What are FORMs COS-1 and COS-2

FORMs COS-1 and COS-2
Ganesh Nair
| Updated: Sep 07, 2022 | Category: CDSCO

The Directorate General of Health Services authorises the Central Drugs Standard Control Organisation to issue cosmetic goods and product licenses. The drugs and cosmetics act 1940 and cosmetics rules 2020 are the two regulations that deal with cosmetic regulations in India. The government has emphasised these rules to ensure that safe, high grade and effective cosmetics are imported into India. An importer is obligated to get a license from CDSCO before importing any cosmetics. The applicant must complete the requirements to obtain a registration certificate in COS-2. In this article, we shall finalise Form COS-1 and COS-2.

What do Forms COS-1 and COS-2 signify?

  • Form COS-1: Form COS-1 is the form required to grant a registration certificate for importing cosmetics into the country as per the cosmetic rules of 2020.
  • Form COS-2: Form COS-2 is the form issued for importing cosmetics in India as per the cosmetic rules of 2020[1].

Documents required for Forms COS-1 and COS-2

The following documents are required to be attached with Forms COS-1 and COS-2

  • A covering letter stating the purpose of the application
  • A letter of authorisation from the manufacturer (this must be duly authenticated)
  • Part 1 of the second schedule D duly filled
  • A detailed list of ingredients
  • Percentage and weight of the ingredients
  • Label of the proposed cosmetic product
  • Testing and Specification methods used by the brand
  • Pack insert
  • The Manufacturing license or undertaking in case there is no provision of manufacturing license from the importing country
  • Duly authenticated copy of Free Sale Certificate
  • Declaration of ‘no Animal testing
  • Declarations to be made for Hexachlorophene content and heavy metal
  • Other documents if prompted by the authority
  • Duly filled application in Form COS-1
  • Original receipt of Bharatkosh payment portal showing the payment of the fee.

Process of Submission of Application Forms COS-1 and COS-2

  • The applicant must log in to the Sugam portal and make an application in form COS-1
  • The manufacturer can himself file the application, or he can appoint an authorised agent/ importer or subsidiary authorised by the Central licensing authority.
  • The applicant must prepare the covering letter; The letter must specify the following details such as the purpose, manufacturing site, size of the pack and details of the earlier import registration certificate (if any).
  • The authorisation from the manufacturer must accompany the application as per the first schedule.
  • The applicant must enlist the ingredients used for creating the product. Few points to remember:
    • The raw material stated in Annexure A of the Indian standard IS:4707 part 2 must not be added.
    • Products containing dyes, pigments or colours should be per the BIS standards.
    • The ingredients of arsenic, lead, and heavy materials should be as per the guidelines of CDSCO.
  • The applicant should upload the label for the proposed cosmetics. This should be according to the labelling regulations laid down by the cosmetic rules.
  • Next, the applicant must attach manufacturing licenses in case there is no provision for a license in authorisation in the country of origin, then attach an undertaking for the same.
  • Further, the declarations need to be made by the application on animal testing declaration and heavy metal and hexachlorophene content.
  • Fill in the details such as
    • Name and address of the authorised agent in India
    • Name and address of the manufacturer and its manufacturing premises
    • Name of the Cosmetic product, variants (if any), pack size (in Indian Metric System), and the product’s manufacturing premises to be registered. The categorisation of the product should be as per the Fourth Schedule of the Cosmetics Rules, 2020
  • Once the steps are completed, make the payment fee via the Bharatkosh Online Payment portal.
  • Lastly, submit the application COS-1 to the CDSCOs Drug Controller general’s office in New Delhi. This document must be must signed and stamped along with the challan of the amount paid for the importer license.

Fee to be paid with Forms COS-1 and COS-2

S.no Purpose Fee
1. Grant of Certificate for each category of cosmetics $1000
2. Retention of Registration Certificate for each category of cosmetics $1000
3. Registration Certificate for an additional category of Cosmetic $1000
4. For registration of each manufacturing site $500
5. For each cosmetic variant $50

Time-period for the grant of Registration certificate in Forms COS-1 and COS-2

If the application is completed in all aspects by the manufacturers, the documents and information are as per part 1 of the second schedule; then the Central licensing Authority shall grant the Import registration certificate to the applicant. If the application is rejected, then the reasons shall be recorded in writing by the authorities and must be communicated to the applicant within six months from the date of the application. CDSCO usually take between 90-180 days to grant the license.

Validity of License for Forms COS-1 and COS-2

The license obtains under forms COS-1 and COS-2 shall be valid for a period of five years.

Conclusion

CDSCO is the body responsible for granting import licenses to cosmetic manufacturers. To obtain a registration certificate for an import license, the applicant has to submit duly filled Forms COS-1. If the central licensing authorities find the application satisfactory, they shall issue the certificate. Introducing such measures has ensured that only good quality and effective products enter the Indian market. If the product or the manufacturer fails to comply with these norms, then their license shall be revoked.

Read our Article:Licensing Authorities for Medical Device Product Registration in India

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Ganesh Nair

Ganesh Nair completed his graduation in law from IP university. He is an ardent researcher who has written various research papers and articles on contemporary legal issues. His keen interest in the field of research made him pursue a career in legal research. His core area of interest include Cyber, IPR and Finance laws.

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